FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
70512-810
11-digit product format
705120810
Labeler code
70512
Product ID
70512-810_4a684065-ba9a-819c-e063-6394a90ac670
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
SOLA Pharmaceuticals, LLC
Application
ANDA206116
Marketing category
ANDA
Marketing start
2023-07-01
Substance
DICLOFENAC SODIUM
Active strength
16.05 mg/mL
Pharmacologic classes
Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac Sodium
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM16.05 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui857700

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70512-810-052025-01-30C16284748780-12cef2736-73e4-d83d-e063-dadaa90ab31fThese highlights do not include all the information needed to use DICLOFENAC SODIUM TOPICAL SOLUTION safely and effectively. See full prescribing information for DICLOFENAC SODIUM TOPICAL SOLUTION. DICLOFENAC SODIUM topical solution 1.5% w/w, for topical use Initial U.S. Approval: 1988

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-810-05Diclofenac Sodium1 in 1 BOXSOLUTION13
70512-810-05Diclofenac Sodium150 mL in 1 BOTTLE, DROPPERSOLUTION1503

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-810DICLOFENAC SODIUM SOLUTION [SOLA PHARMACEUTICALS, LLC]2Current NDC, 2 package rows20230725_11e88ced-cdcf-4101-9297-c4c3dde9d089.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN0b4fd47f-903c-097b-e063-6394a90a49ab4
857700diclofenac sodium 15 MG/ML Topical SolutionSCD0b4fd47f-903c-097b-e063-6394a90a49ab4
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY0b4fd47f-903c-097b-e063-6394a90a49ab4
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY0b4fd47f-903c-097b-e063-6394a90a49ab4
857700diclofenac sodium 1.5 % Topical SolutionPSN11e88ced-cdcf-4101-9297-c4c3dde9d0893
857700diclofenac sodium 15 MG/ML Topical SolutionSCD11e88ced-cdcf-4101-9297-c4c3dde9d0893
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY11e88ced-cdcf-4101-9297-c4c3dde9d0893
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY11e88ced-cdcf-4101-9297-c4c3dde9d0893
857700diclofenac sodium 1.5 % Topical SolutionPSN0c41977f-8dad-1d26-e063-6294a90a9b222
857700diclofenac sodium 1.5 % Topical SolutionPSN3b40a448-3f5e-fe6f-e063-6394a90a32df2
857700diclofenac sodium 15 MG/ML Topical SolutionSCD0c41977f-8dad-1d26-e063-6294a90a9b222
857700diclofenac sodium 15 MG/ML Topical SolutionSCD3b40a448-3f5e-fe6f-e063-6394a90a32df2
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY0c41977f-8dad-1d26-e063-6294a90a9b222
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY3b40a448-3f5e-fe6f-e063-6394a90a32df2
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY0c41977f-8dad-1d26-e063-6294a90a9b222
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY3b40a448-3f5e-fe6f-e063-6394a90a32df2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70512-810-05705120810051 BOTTLE, DROPPER in 1 BOX (70512-810-05) / 150 mL in 1 BOTTLE, DROPPER2023-07-01NoNoCurrent